GlaxoSmithKline, Vir Biotechnology Seek FDA’s EUA for COVID-19 Monoclonal Antibody
GlaxoSmithKline (GSK) and Vir Biotechnology have filed for Emergency Use Authorization (EUA) for their SARS-CoV-2 monoclonal antibody ahead of schedule, having recently stopped their phase 3 trial after seeing significantly positive results.
The pair hope to receive emergency authorization for VIR-7831, a dual-action monoclonal antibody, for treating mild-to-moderate COVID-19 in patients age 12 years and up who are at risk of progressing to hospitalization or death. The companies also filed a biologics license application (BLA) for the coronavirus treatment candidate and are continuing submission talks with the European Medicines Agency and other regulators.
The EUA filing is supported by an interim analysis from their phase 3 trial. The analysis, comprised of data from 583 trial participants, showed the treatment provided an 85 percent reduction in hospitalization and death rates compared to placebo. The treatment proved so effective in the trial that GSK and Vir ended it early after a recommendation by the trial’s independent data monitoring committee (DID, March 12).
GSK added that preclinical data suggest the monoclonal antibody may function in a way that makes it harder for the virus to develop a resistance against it. Data have also suggested that the drug candidate works against concerning viral variants from the UK, South Africa and Brazil, as well as a Californian mutation, the company stated.
So far, the FDA has authorized Eli Lilly’s monoclonal antibody treatment bamlanivimab for COVID-19, as well as bamlanivimab in combination with another Lilly antibody, etesevimab (DID, Feb. 11). The agency has also authorized Regeneron Pharmaceuticals’ antibody combo REGN-COV2 (casirivimab/imdevimab), the first COVID-19 antibody cocktail to receive an EUA from the agency (DID, Nov. 24, 2020).
Recently, the FDA ordered Eli Lilly and Regeneron to evaluate their antibody treatments against viral variants out of concern that new strains may be resistant to them. These concerns have also prompted HHS to restrict nationwide distribution of Lilly’s bamlanivimab (DID, March 17). — James Miessler